Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis (CogEx)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
California State University, Northridge
Information provided by (Responsible Party):
Barbara Giesser, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01219647
First received: October 8, 2010
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

Many persons with Multiple Sclerosis ( MS) have problems with memory and thinking.Exercise has been shown to improve memory and thinking in persons with diseases such as Alzheimer's. This study will investigate whether a program of aerobic exercise can improve memory and thinking in persons with MS


Condition Intervention Phase
Multiple Sclerosis
Behavioral: exercise
Behavioral: stretching
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise as a Strategy to Treat Cognitive Dysfunction in Persons With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    test of attention and information processing


Secondary Outcome Measures:
  • Symbol Digit Modalities Test (SDMT) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    test of attention and information processing

  • VO2 max [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    measure of fitness via oxygen consumption and use

  • Long latency cognitive event related potentials ( LLCERP) [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    electrophysiologic tests of information processing


Estimated Enrollment: 50
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aerobic exercise
Subjects will train on a recumbent cross trainer 20-30 minutes/session for three times/week for six months under supervision of a fitness specialist
Behavioral: exercise
subjects will participate in one of two forms of exercise
Active Comparator: stretching
Subjects will particiate in supervised stretching at same frauency, duration and intensity of aerobic exericse arm
Behavioral: stretching
subjects will particiopate in supervised stretching as described in arm description.

Detailed Description:

Persons with Multiple Sclerosis(MS)will be screened for eligibility and randomized to a protocol with two intervention arms. One group will have aerobic training on a recumbent cross trainer three times a week for 20-30 minutes/session. The other group will participate in stretching exercises at the same frequency and intensity.Total training time will be six months.Outcome measures will include tests of memory and thinking, and fitness measures.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical Diagnosis of MS Complaints of cognitive problems Able to ride a recumbent cross trainer

Exclusion Criteria:

  • Cardiopulmonary or structural disease that would limit ability to participate in exercise training On treatment with chemotherapy or natalizumab Screening score of >50 on PASAT
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219647

Locations
United States, California
UCalifornia at Los Angeles
Los Angeles, California, United States, 90095
CAl State University at Northridge
Northridge, California, United States, 91330
Sponsors and Collaborators
University of California, Los Angeles
California State University, Northridge
Investigators
Principal Investigator: Barbara Giesser, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Barbara Giesser, Clincial Profesor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01219647     History of Changes
Other Study ID Numbers: RG 4174A5/2
Study First Received: October 8, 2010
Last Updated: November 4, 2013
Health Authority: United States: National MS Society

Keywords provided by University of California, Los Angeles:
Multiple Sclerosis
Exercise
Cognition

Additional relevant MeSH terms:
Cognition Disorders
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Delirium, Dementia, Amnestic, Cognitive Disorders
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Mental Disorders
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014